Tufts Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC)

塔夫茨大学牙科、口腔和颅面组织再生联盟 (DOCTRC)

• 批准号: 9001516
• 负责人: Andrew Hoffman
• 金额: $ 20.63万
• 依托单位: TUFTS UNIVERSITY BOSTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-08 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9001516
• 关键词: Achievement; Address; Animal Model; Area; Award; Biocompatible Materials; Biological Assay; Biomedical Engineering; Cells; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Communication; Complex; Conduct Clinical Trials; Craniofacial Abnormalities; Dental; Dental Schools; Development; Development Plans; Devices; Disease; Engineering; Ensure; Environment; Equilibrium; Equipment; FDA approved; Faculty; Goals; Grant; Human; Industry; Injury; Investigational Drugs; Knowledge; Marketing; Medical center; Natural regeneration; Nursing Faculty; Oral; Outcome; Output; Patient Care; Patients; Phase I Clinical Trials; Positioning Attribute; Preclinical Testing; Procedures; Process; Production; Productivity; Protocols documentation; Records; Recruitment Activity; Regenerative Medicine; Research; Research Infrastructure; Research Personnel; Research Support; Resources; Scientist; Side; Source; Staging; Standardization; Stem cells; Structure; Time; TimeLine; Tissue Engineering; Tissues; Tooth structure; Training; Universities; Validation; Veterinary Medicine; Vision; Work; Xerostomia; base; bench to bedside; clinical application; clinical practice; craniofacial; craniofacial repair; efficacy testing; improved; innovation; manufacturing scale-up; medical schools; meetings; member; organizational structure; preclinical study; product development; public health relevance; repaired; scale up; success; tissue regeneration; translational medicine

 DESCRIPTION (provided by applicant): This Stage 1 Planning Grant will develop an overall vision, roadmap, organizational structure and operational procedures for a centralized Tufts Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC) Resource Center (RC). At the completion of this 1-Year Stage 1 Grant, the Tufts DOCTRC organizers will have developed detailed plans for establishing interactive, interdisciplinary DOC-RC teams of biologists, bioengineers, clinicians and other technical experts. This effort will be driven by practicing clinicians involved in everyday DOC patient care in order to ensure building a successful RC infrastructure. Academic clinicians, basic scientist engineers, stem cell biologists, developmental biologists, and industrial liaisons also have been included in the proposed Tufts RC in order to ensure a successful outcome. This Stage 1 Planning Grant will set the stage for the 3-year Stage 2 Award that will be used to establish the Tufts Centralized DOCTRC RC, developing a robust infrastructure to deliver uniform, high-quality technical support and research capacities for preclinical studies. The Stage 2 period will also be used to organize, recruit and integrate several Interdisciplinary Translational Project (ITP) teams into the Tufts Centralized RC. Each of these ITP teams will have identified and developed a specific tissue engineering and regenerative medicine (TE/RM) approach for regeneration of a functional DOC tissue that synergizes with the expertise of one of the Tufts DOC-RC teams. Finally, we anticipate submitting a competitive Stage 3 Consortium Stage application, which will utilize the resources developed in Stage 2 to work with the DOC-RCs and the FDA to advance specific TE/RM clinical applications. The Stage 3 Consortium Stage will complete validation, manufacturing and preclinical testing of the most likely to succeed TE/RM products, and develop Investigational New Drugs/Investigational Devices (IND/IDs) for submission to FDA. The outcome of the DOCTRC-TE/RM will be products and associated protocols ready for initiation of Phase I clinical trials.

 描述（由申请人提供）：第一阶段规划拨款将在完成时为塔夫茨牙科、口腔和颅面组织再生联盟 (DOCTRC) 资源中心 (RC) 制定总体愿景、路线图、组织结构和操作程序。在这项为期一年的第一阶段拨款中，塔夫茨 DOCTRC 组织者将制定详细计划，以建立由生物学家、生物工程师、莫班和其他技术人员组成的互动、跨学科 DOC-RC 团队。这项工作将由参与日常 DOC 患者护理的执业精神科医生推动，以确保建立成功的 RC 基础设施、基础科学家工程师、干细胞生物学家、 发育生物学家和工业联络员也已被纳入拟议的塔夫茨 RC，以确保取得成功结果。这一第一阶段规划拨款将为为期 3 年的第二阶段奖励奠定基础，该奖励将用于建立塔夫茨集中式 DOCTRC。 RC，开发强大的基础设施，为临床前研究提供统一、高质量的技术支持和研究能力。第二阶段还将用于组织、招募和整合多个跨学科转化项目（ITP）。每个 ITP 团队都将确定并开发一种特定的组织工程和再生医学 (TE/RM) 方法，用于再生功能性 DOC 组织，该方法与塔夫茨 DOC-RC 之一的专业知识相协同。最后，我们预计将提交一份具有竞争力的第 3 阶段联盟阶段申请，该申请将利用第 2 阶段开发的资源与 DOC-RC 和 FDA 合作推进特定的 TE/RM 临床申请。 3 联盟阶段将完成最有可能成功的 TE/RM 产品的验证、制造和临床前测试，并开发研究性新药/研究性器械 (IND/ID)，以提交给 FDA。 DOCTRC-TE/RM 的结果将。准备好启动 I 期临床试验的产品和相关方案。